Product code HKM
- Device name
- Retinoscope, Battery-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1780
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964338 | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT | Rudolf Riester GmbH & Co. KG | 1997-01-09 |
| K950791 | STREAK RETINOSCOPE RX-3 | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950792 | STREAK RETINOSCOPE RX-3A | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950793 | SPOT RETINOSCOPE RX-3SP | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950794 | STREAK RETINOSCOPE RX-RC | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950795 | STREAK RETINOSCOPE RX-RP | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K840840 | GENERATED RETINAL REFLEX IMAGERY SYS | Electro Optical Instruments | 1984-07-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06945095544876 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544852 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095543855 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095543930 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544074 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544159 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544210 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544302 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544470 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544524 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544531 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544562 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544579 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544814 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095543749 | zumax | Zumax Medical Co., LTD | 2026-05-18 |
| 04053755202508 | BETA 200 LED RETINOSCOPE | Heine Optotechnik GmbH & Co. KG | 2024-07-16 |
| 04053755119967 | BETA 200 LED RETINOSCOPE | Heine Optotechnik GmbH & Co. KG | 2024-07-16 |
| 00732094087727 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 04053755191673 | BETA 200 LED RETINOSCOPE | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04053755193202 | BETA 200 RETINOSCOPE | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04053755193219 | BETA 200 RETINOSCOPE | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 00732094098914 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2021-04-22 |
| 00732094098952 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2021-04-22 |
| 04045396010819 | ri-scope® retinoscope head slit XL 3.5 V | Rudolf Riester GmbH | 2021-01-28 |
| 04045396129931 | ri-scope® retinoscope head slit XL 3.5 V, | Rudolf Riester GmbH | 2021-01-28 |
| 04045396140974 | ri-vision with retinoscope slit XL 3.5 V, C-handle | Rudolf Riester GmbH | 2021-01-28 |
| 04045396182646 | ri-vision with slit retinoscope XL/LED 3,5V, C han | Rudolf Riester GmbH | 2021-01-28 |
| 04045396182660 | ri-vision with slit retinoscope XL/LED 3,5V/120V, | Rudolf Riester GmbH | 2021-01-28 |
| 04045396182783 | ri-vision with slit retinoscope XL/LED 3,5V, C han | Rudolf Riester GmbH | 2021-01-28 |
| 00732094087703 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2020-01-16 |